Tag: sustained release

Categories
Glaucoma Treatments

A Biodegradable Implant for Glaucoma

Featured Image for Sustained Release Implant Treats Glaucoma | Retina Eye Doctor
Featured Article Image | Durysta | RetinaEyeDoctor.com

Novel Durysta improves compliance for treatment of glaucoma.

Sustained release technology solves an old treatment issue—patients who don’t take their medicine or don’t take it properly.

Durysta™ was approved by the FDA in March of this year to deliver medication to control open-angle glaucoma. It is the first implantable sustained-release delivery system for reducing intraocular pressure.

Biodegradable Implant for the Eye

Durysta is a tiny implant smaller than a grain of rice. It comes preloaded in its own injection delivery system. The implant is placed underneath the cornea, on the edge of the iris where it will deliver intraocular pressure reducing medication to the exact area it is needed. Once the medication is all dispensed the implant biodegrades. 

Implants are made biodegradable by using compounds present in nature to create polymers. These polymer plastics degrade, and the body naturally eliminates the wastes.  The system is very similar to Ozurdex, a sustained release platform used to treat complications of diabetic retinopathy and retinal vascular occlusions.

The implantation is not painful and can be done in a doctor’s office.

Implant Release Bimatoprost

The implant releases Bimatoprost, a drug that lowers intraocular pressure by increasing the outflow of aqueous humour. While the drug has been used as pressure-reducing eye drops since being approved by the FDA in 2001, the sustained release formulation is novel.

Advantages of Implanted Sustained-Release Medication 

Non-adherence to glaucoma treatment has been a problem for many years. Reports vary, and non-adherence has been reported to be from 30% to 80% of patients treated. Having an implant that delivers the medication will eliminate the issue of non-adherence in the patients receiving the implants.

How does Glaucoma Damage Eyesight?

A buildup of fluid (aqueous humor) causes eye pressure to increase. The increased eye pressure damages the optic nerve causing it to gradually deteriorate. 

The first symptoms of this optic nerve deterioration is a subtle loss of peripheral (side) vision.

Damage to the optic nerve is irreversible. The cable of nerve fibers that carry visual signals to the brain do not have the ability to regenerate or heal. That’s why it is important to begin treating glaucoma before any vision loss occurs.

How is Glaucoma Diagnosed?

The presence of glaucoma can be discovered during a routine eye exam. 

In the early stages, before it causes any vision loss, glaucoma has no symptoms. Having regular eye exams can detect glaucoma in the very early stages and treatment to lower eye pressure can be started.

Randall V. Wong, M.D.
Retina Specialist
Virginia and Washington D.C.

Categories
Diabetic retinopathy Treatments

FDA Denies Iluvien

Iluvien Denied by FDA

The Food and Drug administration fails to approve Iluvien for the treatment of diabetic retinopathy and cites the need for more safety information in addition to concerns about the safety of the manufacturing process of Iluvien.   Alimera Sciences had hoped to gain approval by the end of December 2010, instead, it was told by the FDA that more information was needed.

Safety and Efficacy of Iluvien

Data from almost 1000 patients were included in the FDA submission.  If you remember, Alimera Sciences received a “Priority Review” from the FDA when the application was filed last summer.  A “Priority Review” accelerates this last leg of the FDA approval process.

Instead, the FDA is asking for additional safety/efficacy information covering 36 months after treatment instead of the 24 months provided.

Is Manufacturing Safe?

There were also concerns regarding the manufacturing, packaging and sterilization of Iluvien, though no specifics were noted.

What Does this Mean?

We’ve now heard about Iluvien for diabetic macular edema for over a year.  At the outset, the news has been promising and the technology exciting.  For patients with diabetic macular edema, this drug promises options to the old standby …laser treatment.

Iluvien may be the second drug approved that is based on technology to offer sustained drug delivery into the eye.  Ozurdex, a similar product, has been in use since the summer of 2009 and is used for retinal vein occlusions.

While promising, the FDA plods slowly, yet thoroughly.  The request for additional data indicates that this product is probably effective for treating macular edema, yet recommendations need to be made regarding is use.  Hence, the need for additional dtate.

Had the product been rejected, or requests for additional clinical trials, this would have been a clearer signal of failure.

In the end, though disappointing, the company hopes to have a marketable product by the end of 2011.

Hang in there.

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Categories
My Opinion

Mr. Ozurdex's Vision is Sustained

“Mr. Ozurdex” is a patient in whom I injected Ozurdex® for the treatment of a branch retinal vein occlusion (BRVO).  Ozurdex, is the first sustained release drug delivery system for the eye.  It was FDA approved for the treatment of retinal vein occlusions last summer (RVO).  Allergan began marketing Ozurdex shortly after the FDA approval.

Mr. Ozurdex was given an intraocular injection in early January.  Upon his first return visit, he noted a dramatic improvement in his vision!  At the time of injection, he was legally blind.  After only 2 weeks, his vision improved enough to read.

Upon his return this week, his vision remains stable, he can still read and there are no concerns of any complications.  As with any injection of steroid, in increase in eye pressure may occur.  Happily, there is none.

Mrs. Ozurdex is Still Worried

“Mrs. Ozurdex,” on the other hand, is still not seeing any differently.  About the same time, I injected Ozurdex for treatment of a central retinal vein occlusion (CRVO). There are two types of retinal vein occlusions; central (CRVO) and branch (BRVO).

Mr. “O” had a BRVO.  The visual prognosis has always been better with a branch retinal vein occlusion.

Mrs. “O” had a CRVO.  The visual prognosis has always been much poorer with a central retinal vein occlusion.

Early Visual Results May be Misleading

I have cautioned both patients.  First, with Mr. Ozurdex, while the results are fantastic, the real question is whether or not we can sustain this improvement.  He may require another injection of Ozurdex, plain steroid, or even anti-VEGF, such as Avastin.

I have encouraged Mrs. Ozurdex to remain positive.  First, she is no worse than when we decided on the sustained release therapy, and second, the drug will be released for several more months to come.  There is still a great deal of blood and edema that can resolve, so who is to say how well she’ll fare over the next four months?

What Does This Mean? It is exciting to try a new therapy especially in an area where there have traditionally been few therapeutic options.  It is also easy to be biased, good or bad, about the results of a new treatment.

I have no way of really knowing if every patient is going to respond like Mr. “O.”  We have yet to define the perfect patient for receiving the new steroid releasing device, perhaps everyone will.

It’s too early to tell if Mrs. “O” is exhibiting a typical or atypical response to Ozurdex given her condition.

Though the FDA has given its approval, it doesn’t necessarily translate into a positive outcome.

Categories
Diabetic retinopathy Treatments

Iluvien® For Diabetic Macular Edema Has Eyes on FDA

™Alimera Sciences’ “Iluvien®” moves closer to FDA approval for the treatment of diabetic macular edema.  Iluvien is an extended release drug delivery system designed for direct intravitreal injection to the eye.  Iluvien will release a steroid, fluocinolone acetonide, for up to 36 months to treat retinal swelling.  The company has announced pivotal results in the ongoing FAME (Fluocinolone acetonide in diabetic macular edema) study.  This is a phase 3 FDA clinical trial.

An earlier post covered Iluvien’s safety and efficacy in phase 2 trials for the treatment of diabetic macular edema.

Diabetic Macular Edema is the most common complication of diabetic retinopathy.  The traditional laser for diabetic retinopathy has been usual treatment for about 30 years.  I have written previously about the emergence of new treatments and new technologies to treat the diabetic macular edema.  Intravitreal steroid injections, anti-VEGF and sustained release intraocular drug delivery systems are all the rage.

FDA Clinical Trials dictate how medicines are approved for treatment of disease in the U.S.  I have always cautioned that you must consider a “treatment” only if it has already been FDA approved.  Most of what is advertised as treatment is neither FDA approved nor even studied.

There are 4 different steps to passing the FDA requirements. There are 3 phases of clinical trials (sometimes an additional phase 4 is required) and the NDA (New Drug Application).

The phase 3 clinical trial (FAME) is almost complete.  The study will proceed to 36 months.  The early phase 3 findings indicate improvement in vision in about 25-30% of patients after the first 24 months of the study.

What Does This Mean? This is huge.  It means that there is merit to what the company anticipates.  Technically, phase III trials determine if the drug is useful and confirms safety.

New Drug Application (NDA) is usually the last step for a company, or sponsor, to be allowed to market and sell the drug.  Alimera expects NDA submission later in 2010 after completion and analysis of the phase 3 data.

Alimera’s Iluvien is close to reality for the treatment of diabetic macular edema.

For fun, compare the status of this drug, Iluvien, to E10030.  I wrote about Ophthotech’s E10030 a few days ago.  E10030 is an anti-PDGF aptamer that treats wet macular degeneration.  This drug is about to enter phase 2.

“Randy”

Randall V. Wong, M.D.
Ophthalmologist, Retina Specialist
Fairfax Virginia

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